Interaction Between Nalbuphine and Morphine in PCA | NCT00155233

Studies
Interaction Between Nalbuphine and Morphine in PCA

NCT00155233

Sponsor

National Taiwan University Hospital

Status

Unknown status

Last Update Posted

Nov 23, 2005Estimated

Enrollment

200

Phase

Phase 4

Conditions

Postoperative Pain

Interventions

Nalbuphine and morphine

Countries

Taiwan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2005

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2005

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Sep 8, 2005

First Submission Date that Met QC Criteria

Sep 8, 2005

First Posted Date

Sep 12, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 22, 2005

Last Update Posted Date

Nov 23, 2005Estimated

Description Module

Brief Summary

Nalbuphine is opioid mu receptor antagonist and kappa receptor agonist
This study was designed to investigate the interaction between nalbuphine and morphine

Detailed Description

Nalbuphine is opioid mu receptor antagonist and kappa receptor agonist
This study was designed to investigate the interaction between nalbuphine and morphine
The analgesic effect and opioid-related side effects will be investigated

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

200

Name	Type	Description	Arm Group Labels	Other Names
Nalbuphine and morphine	Drug

Measure	Description	Time Frame
analgesic effect

Measure	Description	Time Frame
incidence of opioid-related side effects

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age 18-65 y/o
Female patients of ASA physical status I to III
Scheduled for elective abdominal hysterectomy, myomectomy, or excision of ovarian tumor

Exclusion Criteria:

Patients with a definite diagnosis of chronic pain syndrome, psychiatric disorders, or drug abuse (include opioids, NSAIDs, sedatives, antidepressants)
Intraoperative fentanyl use > 3 μg/kg
Patients with definite diagnosis of esophageal reflux syndrome
Use of sedatives, antiemetics, or antipruritics within 24 hours before operation
Surgery > 4 hours or laparoscopy surgery

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Wei-Zen Sun, MD	National Taiwan University Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
National Taiwan University Hospital	Recruiting	Taipei		100	Taiwan

Condition Browse Module

MeSH Terms

ID	Term
D010149	Pain, Postoperative

Ancestor Terms

ID	Term
D011183	Postoperative Complications
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D010146	Pain

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D009266	Nalbuphine
D009020	Morphine

Ancestor Terms

ID	Term
D009019	Morphinans
D053610	Opiate Alkaloids
D000470	Alkaloids
D006571	Heterocyclic Compounds

Browse Leaves

Not provided

Browse Branches

Not provided